BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

    MDR report key: 6689103 · Received July 6, 2017

    Report

    Report Number
    1020379-2017-00052
    Event Type
    Injury
    Date Received
    July 6, 2017
    Report Date
    June 28, 2017
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS.

    Description of Event or Problem · 1

    I ACCIDENTLY SWALLOWED THE POLIDENT WATER [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A MALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TABLET (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL INGESTION OF DRUG. THE ACTION TAKEN WITH POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND ACCIDENTAL INGESTION OF DRUG WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ADDITIONAL DETAILS: THE ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2017. THE CONSUMER REPORTED THAT, "I ACCIDENTLY SWALLOWED THE POLIDENT WATER. I NO LONGER HAVE THE BOX. IS THERE ANY THING THAT IS GOING TO HAPPEN TO ME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470588 POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS DENTURE CLEANSER EFT BLOCK DRUG CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other